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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Integra® - 10381780248125

Integra® External Fixation System The provisional heel support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225050
In Commercial Distribution

  • M269122250501 ()
  • 10381780248125 ()

  • 6.238 in L
12225050

  • External orthopaedic fixation system, reusable

Integra® - 10381780248118

Integra® External Fixation System The provisional calf support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225040
In Commercial Distribution

  • M269122250401 ()
  • 10381780248118 ()

  • 6.883 in L
12225040

  • External orthopaedic fixation system, reusable

Integra® - 10381780247975

Integra® External Fixation System The k-wire guide is used during strut assembly in the external fixation system.
Ascension Orthopedics, Inc.
12225315
In Commercial Distribution

  • M269122253151 ()
  • 10381780247975 ()

  • 2.56 in L
12225315

  • Orthopaedic guidewire, reusable

Integra® - 10381780247951

Integra® Titanium Bone Wedge System The Cotton Wedge Trial Caddy is a smaller, removable container with a lid that can rest within the base.
Ascension Orthopedics, Inc.
CSA-1006-04
Not in Commercial Distribution

  • M269CSA1006041 ()
  • 10381780247951 ()

  • 6.625 in L
CSA100604

  • Instrument tray, reusable

Integra® - 10381780247937

Integra® Titanium Bone Wedge System The LCL Wedge Trial Caddy is a smaller, removable container with a lid that can rest within the base.
Ascension Orthopedics, Inc.
CSA-1006-02
Not in Commercial Distribution

  • M269CSA1006021 ()
  • 10381780247937 ()

  • 6.625 in L
CSA100602

  • Instrument tray, reusable

Integra® - 10381780247906

Integra® Titanium Bone Wedge System The tamp is used to impact the implant into place.
Ascension Orthopedics, Inc.
TMP-1006-00
Not in Commercial Distribution

  • M269TMP1006001 ()
  • 10381780247906 ()

  • 6.0 in L
TMP100600

  • Surgical tamp, reusable

Titan™ - 10381780247586

Titan™ Total Shoulder System The head cutting template has a right orientation. It is used for head resection.
Ascension Orthopedics, Inc.
T0920040001R
In Commercial Distribution

  • M269TMP0920040001R1 ()
  • 10381780247586 ()

  • 3.0 in L
TMP-0920-040-001R

  • Surgical implant template, reusable

Titan™ - 10381780247579

Titan™ Total Shoulder System The head cutting template has a left orientation. It is used for head resection.
Ascension Orthopedics, Inc.
T0920040001L
In Commercial Distribution

  • M269TMP0920040001L1 ()
  • 10381780247579 ()

  • 3.0 in L
TMP-0920-040-001L

  • Surgical implant template, reusable

Titan™ - 10381780247371

Titan™ Reverse Shoulder System The torx-25 screwdriver shaft with quick connect is used to advance the screw just before it is fully seated.
Ascension Orthopedics, Inc.
SCR096007201
In Commercial Distribution

  • M269SCR0960072011 ()
  • 10381780247371 ()

  • 9.80 in L
SCR-0960-072-01

  • Surgical screwdriver, reusable

Titan™ - 10381780247364

Titan™ Reverse Shoulder System The slotted torx-15 for 4.5mm screw locking caps is used to thread and tighten the locking caps directly over the superior and inferior screw heads.
Ascension Orthopedics, Inc.
SCR096006301
In Commercial Distribution

  • M269SCR0960063011 ()
  • 10381780247364 ()

  • 5.5 in L
SCR-0960-063-01

  • Surgical screwdriver, reusable

Integra® - 10381780247333

Integra®Surgical Instruments The 1/8 Hex Driver is used to tighten or loosen screws.
Ascension Orthopedics, Inc.
SR0920060001
In Commercial Distribution

  • M269SCR09200600011 ()
  • 10381780247333 ()

  • 5.5 in L
SCR-0920-060-001

  • Surgical screwdriver, reusable

Titan™ - 10381780247289

Titan™ Reverse Shoulder System Peripheral Reamer Eccentric MOD The peripheral eccentric reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RMR096007602
In Commercial Distribution

  • M269RMR0960076021 ()
  • 10381780247289 ()

  • 4.16 in L
RMR-0960-076-02

  • Bone-resection orthopaedic reamer, reusable

Titan™ - 10381780247272

Titan™ Reverse Shoulder System Peripheral Reamer, Concentric The peripheral concentric reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RMR096007601
In Commercial Distribution

  • M269RMR0960076011 ()
  • 10381780247272 ()

  • 4.0 in L
RMR-0960-076-01

  • Bone-resection orthopaedic reamer, reusable

Integra® - 10381780247043

Integra®Surgical Instruments The Integra Surgical Instruments mini ratchet handle is provided green in color.
Ascension Orthopedics, Inc.
RM1011S03
In Commercial Distribution

  • M269RM1011S031 ()
  • 10381780247043 ()

  • 5.51 in L
RM1011-S03

  • Surgical instrument handle, non-torque-limiting

NuGrip® - 10381780246787

Integra® NuGrip® The NuGrip Retractor facilitates access to the joint by withdrawing muscles and tissues for exposure of the joint area.
Ascension Orthopedics, Inc.
RET44300
In Commercial Distribution

  • M269RET443001 ()
  • 10381780246787 ()

  • 6.6 in L
RET-443-00

  • Hand-held surgical retractor, reusable

Movement® - 10381780246664

Movement® Great Toe System Proximal Phalanx Broach The Movement Great Toe Proximal Phalanx Broach is used to prepare a cavity that provides a press fit for the implant.
Ascension Orthopedics, Inc.
PPB-890-00
In Commercial Distribution

  • M269PPB890001 ()
  • 10381780246664 ()

  • 2.35 in L
PPB89000

  • Orthopaedic broach

Titan™ - 10381780246633

Titan™ Total Shoulder System Round Mini Glenoid Peg Punch
Ascension Orthopedics, Inc.
PUN-0940-043-000
Not in Commercial Distribution

  • M269PUN09400430001 ()
  • 10381780246633 ()

  • 8.9 in L
PUN-0940-043-000

  • Bone cutter

Construct® - 10381780246602

Construct® Ankle Fusion Plate System The PF pin with AO quick connect is used for temporary fixation.
Ascension Orthopedics, Inc.
PFP-5010-32
Not in Commercial Distribution

  • M269PFP5010321 ()
  • 10381780246602 ()

  • 3.46 in L
PFP-5010-32

  • Orthopaedic implant aiming arm

Construct ™ - 10381780246534

Construct® Ankle Fusion Plate System The Plate Bending Handles are used to bend pre-countored plates to match specific patient anatomy.
Ascension Orthopedics, Inc.
PBH-5010-01
Not in Commercial Distribution

  • M269PBH5010011 ()
  • 10381780246534 ()

  • 7.78 in L
PBH501001

  • Manual orthopaedic bender, reusable

Integra® - 10381780246473

Silicone PIP Cut Guide
Ascension Orthopedics, Inc.
OSG44200
In Commercial Distribution

  • M269OSG442001 ()
  • 10381780246473 ()

  • 2.39 in L
OSG-442-00

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246466

Modular Radial Head Osteotomy Cut Guide, MRH
Ascension Orthopedics, Inc.
OSG35001
In Commercial Distribution

  • M269OSG350011 ()
  • 10381780246466 ()

  • 6.0 in L
OSG-350-01

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246374

PyroCarbon PIP Total Joint PIP Vertical Cut Guide
Ascension Orthopedics, Inc.
OSG20000
In Commercial Distribution

  • M269OSG200001 ()
  • 10381780246374 ()

  • 2.39 in L
OSG-200-00

  • Custom-made orthopaedic/craniofacial surgical guide

Ascension® - 10381780246367

Ascension® MCP Osteotomy Guide, Proximal
Ascension Orthopedics, Inc.
OSG10000P
In Commercial Distribution

  • M269OSG10000P1 ()
  • 10381780246367 ()

  • 2.04 in L
OSG-100-00P

  • Orthopaedic reamer guide

Ascension® - 10381780246350

Ascension® MCP Osteotomy Guide, Distal
Ascension Orthopedics, Inc.
OSG10000D
In Commercial Distribution

  • M269OSG10000D1 ()
  • 10381780246350 ()

  • 2.48 in L
OSG-100-00D

  • Orthopaedic reamer guide

MemoFix® Super Elastic Nitinol Staple System - 10381780246251

Integra® MemoFix® Staple System The MemoFix removal tool is used to remove staples by lifting the staple bridge to a position in which the staple spreader can be engaged.
Ascension Orthopedics, Inc.
MS-2940
In Commercial Distribution

  • M269MS29401 ()
  • 10381780246251 ()

  • 3.5 in L
MS-2940

  • Orthopaedic inorganic implant inserter/extractor, reusable

MemoFix® Super Elastic Nitinol Staple System - 10381780246237

Integra® MemoFix® Staple System The MemoFix tamp is used to push down the staple into the bone.
Ascension Orthopedics, Inc.
MS-2920
In Commercial Distribution

  • M269MS29201 ()
  • 10381780246237 ()

  • 6.02 in L
MS-2920

  • Surgical tamp, reusable

Titan™ - 10381780245858

Titan™ Reverse Shoulder System The reamer guide body inserter/extractor is used to assist with the preparation and placement of trials and implants in the reverse shoulder system.
Ascension Orthopedics, Inc.
INS096004901
In Commercial Distribution

  • M269INS0960049011 ()
  • 10381780245858 ()

  • 8.63 in L
INS-0960-049-01

  • Orthopaedic inorganic implant inserter/extractor, reusable

Titan™ - 10381780245810

Titan™ Reverse Shoulder System The stand is used as a base during stem impaction.
Ascension Orthopedics, Inc.
IMS096007001
In Commercial Distribution

  • M269IMS0960070011 ()
  • 10381780245810 ()

  • 2.2 in H
IMS-0960-070-01

  • Surgical implant/trial-implant/sizer holder, reusable

Integra® - 10381780245803

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
IMP90001
In Commercial Distribution

  • M269IMP900011 ()
  • 10381780245803 ()

  • 6.33 in L
IMP-900-01

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245674

Titan™ Reverse Shoulder System Liner Impactor The Liner Impactor is used to properly fit the liner into place.
Ascension Orthopedics, Inc.
IMP096007101
In Commercial Distribution

  • M269IMP0960071011 ()
  • 10381780245674 ()

  • 8.43 in L
IMP-0960-071-01

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245667

Titan™ Reverse Shoulder System Glenosphere Impactor The Glenosphere Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IMP096006601
In Commercial Distribution

  • M269IMP0960066011 ()
  • 10381780245667 ()

  • 8.79 in L
IMP-0960-066-01

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245650

Titan™ Reverse Shoulder System The Glenoid Baseplate Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IMP096006401
In Commercial Distribution

  • M269IMP0960064011 ()
  • 10381780245650 ()

  • 8.26 in L
IMP-0960-064-01

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245643

Titan™ Total Shoulder System IMPACTOR, HEAD, TSS The Head Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IP0920079501
In Commercial Distribution

  • M269IMP09200795011 ()
  • 10381780245643 ()

  • 6.24 in L
IMP-0920-0795-01

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245636

Titan™ Total Shoulder System Glenoid Impactor The Glenoid Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IP0920064001
In Commercial Distribution

  • M269IMP09200640011 ()
  • 10381780245636 ()

  • 8.8 in L
IMP-0920-064-001

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245629

Titan™ Total Shoulder System Stem Impactor The Stem Impactor is placed over the implant stem to impact it into the canal for press fit.
Ascension Orthopedics, Inc.
IP0920055001
In Commercial Distribution

  • M269IMP09200550011 ()
  • 10381780245629 ()

  • 4.3 in L
IMP-0920-055-001

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245612

Titan™ Reverse Shoulder System The IM head cutting guide is used during implant head resection.
Ascension Orthopedics, Inc.
IMC096004301
In Commercial Distribution

  • M269IMC0960043011 ()
  • 10381780245612 ()

  • 2.06 in L
IMC-0960-043-01

  • Custom-made orthopaedic/craniofacial surgical guide

Titan™ - 10381780245551

Titan™ Total Shoulder System Mini Glenoid Holder
Ascension Orthopedics, Inc.
HDR-0940-048-001
In Commercial Distribution

  • M269HDR09400480011 ()
  • 10381780245551 ()

  • 9.9 in L
HDR-0940-048-001

  • Orthopaedic implant/instrument assembling device

BioMotion® Cannulated 1st MPJ Hemi System - 10381780245513

Integra® BioMotion® Cannulated Hemi System The slide hammer is used to assist with implant placement into the bone.
Ascension Orthopedics, Inc.
HM 3010
In Commercial Distribution

  • M269HM30101 ()
  • 10381780245513 ()

  • 8.14 in L
HM 3010

  • Orthopaedic implant impactor, reusable

BioMotion® Cannulated 1st MPJ Hemi System - 10381780245506

Integra® BioMotion® Cannulated Hemi System BioMotion Slide Broach The BioMotion Slide Broach is used to prepare a cavity that provides a press fit for the implant.
Ascension Orthopedics, Inc.
HM 3005
In Commercial Distribution

  • M269HM30051 ()
  • 10381780245506 ()

  • 8.24 in L
HM 3005

  • Orthopaedic broach

Titan™ - 10381780245490

Titan™ Total Shoulder System The humeral depth stop is used for precise measurement.
Ascension Orthopedics, Inc.
HS0920069001
In Commercial Distribution

  • M269HDS09200690011 ()
  • 10381780245490 ()

  • .76 in W
HDS-0920-069-001

  • Surgical depth gauge, reusable

Titan™ - 10381780245452

Titan™ Total Shoulder System The anti-rotation peg holder is used to assist with the placement of the anti-rotation peg in the Titan Total Shoulder system.
Ascension Orthopedics, Inc.
HL0920075001
In Commercial Distribution

  • M269HDL09200750011 ()
  • 10381780245452 ()

  • 8.5 in L
HDL-0920-075-001

  • Orthopaedic implant/instrument assembling device

Titan™ - 10381780245445

Titan™ Total Shoulder System The stem trial handle is used to assist with the placement of the stem trial.
Ascension Orthopedics, Inc.
HL0920043001
In Commercial Distribution

  • M269HDL09200430011 ()
  • 10381780245445 ()

  • 6.35 in L
HDL-0920-043-001

  • Surgical instrument handle, non-torque-limiting

Construct ™ - 10381780245407

Construct® Ankle Fusion Plate System The guide pin targeting sleeve is attached to the guide pin targeting base in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTS-1000-01
Not in Commercial Distribution

  • M269GTS1000011 ()
  • 10381780245407 ()

  • 3.0 in L
GTS100001

  • Surgical drill guide, reusable

Construct® - 10381780245391

Construct® Ankle Fusion Plate System The targeting base knob is used in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTB-1000-03
Not in Commercial Distribution

  • M269GTB1000031 ()
  • 10381780245391 ()

  • 1.935 in L
GTB-1000-03

  • Orthopaedic implant/instrument assembling device

Construct® - 10381780245346

Construct® Ankle Fusion Plate System The Smith Peterson straight osteotome is used for cutting bone.
Ascension Orthopedics, Inc.
gS 52.5520
Not in Commercial Distribution

  • M269GS5255201 ()
  • 10381780245346 ()

  • .75 in W
gS 52.5520

  • Orthopaedic osteotome

Integra® - 10381780245308

Integra®Surgical Instruments The Guide Pin is used in conjunction with the cup and cone reamers.
Ascension Orthopedics, Inc.
GDW-895-00
In Commercial Distribution

  • M269GDW895001 ()
  • 10381780245308 ()

  • 6.0 in L
GDW-895-00

  • Orthopaedic guidewire, reusable

Titan™ - 10381780245278

Titan™ Total Shoulder System The head cutting depth gauge can be used to assess the cutting plane.
Ascension Orthopedics, Inc.
GU0920058001
In Commercial Distribution

  • M269GAU09200580011 ()
  • 10381780245278 ()

  • 5.25 in L
GAU-0920-058-001

  • Surgical depth gauge, reusable

Integra® - 10381780245261

Integra®Surgical Instruments The torque limiter is used during assembly and implantation of devices.
Ascension Orthopedics, Inc.
G207153
In Commercial Distribution

  • M269G2071531 ()
  • 10381780245261 ()

  • 4.52 in L
G207153

  • Surgical instrument torque limiter

Ti6® Internal Fixation System - 10381780245056

Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 3.0 and 4.0mm screws.
Ascension Orthopedics, Inc.
FS2060
In Commercial Distribution

  • M269FS20601 ()
  • 10381780245056 ()

  • 3.516 in L
FS2060

  • Surgical drill guide, reusable

Ti6® Internal Fixation System - 10381780245049

Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 2.0 and 2.5mm screws.
Ascension Orthopedics, Inc.
FS2050
In Commercial Distribution

  • M269FS20501 ()
  • 10381780245049 ()

  • 3.074 in L
FS2050

  • Surgical drill guide, reusable
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